USPTO Patents Application 09826212

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Appl. No. 09/826,212

Remarks

Upon entry of the foregoing amendments, claims 117-220 are pending in the
application, with claims 117, 127, 135, 143, 151, 160, 176, 184, 191, and 210 being the
independent claims. Amendments to claims 118, 119, 152, 161, 169, 176, 184, 194, 198,
200, 202, 203 and 210 are sought. Claims 117, 120-175, 191-197, 199, 201 and 203-209
were previously allowed by the Examiner in the Office Action of March 11, 2003.

The foregoing amendments to the claims are in response. to the Examiner's objections
and rejections, and are believed to place the claims into condition for allowance or into
better condition for consideration on appeal. Support for the foregoing amendments to the
claims may be found throughout the description, and in the original claims. Support for the
claims can be found, inter alia, at page 25, line 1 to page 33, line 4, in Examples 5 and 6
(pages 65 to 67), and Figures 2 and 5. No new claims are sought to be added. These
amendments do not raise new issues or require further search by the Examiner. These
changes are believed to introduce no new matter, and their entry is respectfully requested.
Reconsideration of this Application is respectfully requested.

Based on the above amendments and the following remarks, Applicants respectfully
request that the Examiner reconsider all outstanding objections and rejections and that they
be withdrawn.

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Objections to the claims

The Examiner objected to claims 198, 200 and 202 for omitting the word "sequence"
after "amino acid." (Paper No. 12, at 2.) In response to the objection, Applicants have
added the term "sequence" after "amino acid" in claims 1 98, 200 and 202, thereby obviating
the Examinees objection.

The Examiner objected to claims 118 and 1 1 9 as being of improper dependent form
for failing to further limit the subject matter of a previous claim. (Paper No. 12, at 3.)
Applicants respectfully disagree, as Applicants believe that claims 118 and 119 are in proper
dependent form. However, to more clearly state their dependencies, Applicants have
amended claims 118 and 119. Claim 1 17 is drawn to an isolated polypeptide comprising
amino acids 1 to 233 of SEQ ID NO:2. Amended claim 1 18 is drawn to the polypeptide of
claim 117, and further comprises additional amino acids -25 to 1, inclusive. Claim 1 19 is
drawn to the polypeptide of claim 118, and further comprises additional amino acid -26.
Thus, both claims 118 and 119 recite additional amino acids compared to their respective
base claims. Since amended claims 118 and 1 19 are in proper dependent form, withdrawal
of this objection is respectfully requested.

Rejections under 35 US.C. § 112, first paragraph, written description

The Examiner rejected claims 176-190 and 210-220 under 35 U.S.C. § 112, first
paragraph, for alleged lack of written description. (Paper No. 12, at 3.) The Examiner
retained the original grounds of rejection and deemed Applicant's arguments nonpersuasive.
However, the Examiner found persuasive AppHcant f s_arguments— for polypeptides 90%1:o
95% identical to the polypeptide of SEQ ID NO:2, and for polypeptides comprising the

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Appl. No. 09/826,212

major domains of the polypeptides that have the activity of binding TRAIL." (Paper 12, at
6.)

The Examiner further argues that "[f]ollowing Applicants' arguments, a polypeptide
comprising 10, 5 or even 2 amino acids of the polypeptide of SEQ ID NO: 2 would also be
adequately described, as long as the polypeptide bound an antibody with specificity for a
reference polypeptide consisting of SEQ ED NO: 2, and these polypeptides require virtually
no structure." (Paper No. 12, at 5.) Applicants respectfully disagree.

Claims 176-190 and 210-220 recite polypeptides comprising 30 or 50 contiguous
amino acids from SEQ ID NO: 2. The specification provides written description support for
these species at, inter alia, page 3 1 , line 27, to page 32, line 4. Applicants have not claimed
polypeptides comprising 2, 5, or even 10 amino acids, nor have they provided reasoning to
imply claims to polypeptides comprising 2, 5, or 10 amino acids.

The Examiner further asserts that n [w]hile the written description guidelines indicate
that a molecule may be adequately described through a combination of structure and
function, the degree of structure recited must also be considered." (Paper No. 12, at 5.) The
Examiner asserts that the antibody-binding function of the unamended claims did "not
provide adequate structure to meet the written description guidelines." However, the
Examiner considered that Applicants arguments were persuasive for polypeptides that bind
TRAIL.

Applicants have amended claims 176, 184, and 210 to recite polypeptides that bind
TRAIL. The new elements of independent claims 176, 184, and 210 are incorporated into
their respective dependent claims 1 77-1 83, JL85J-89, and-2 14 -220^ T-hus^-Applicants define
the genera by reference both to a structural component and a functional component that was

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deemed sufficiently specific by the Examiner. These amendments introduce no new matter,
and their consideration and entry are respectfully requested.

For all of the above reasons, Applicants assert that the written description
requirements have been met and that the Examiner's rejection is overcome. Accordingly,
claims 176-190 and 210-220 are now in condition for allowance. Reconsideration and
withdrawal of the rejection under 35 U.S.C. § 1 1 2, first paragraph, is respectfully requested.

Rejections under 35 U.S.C. § 112, second paragraph, indefiniteness

The Examiner rejected claim 202 under 35 U.S.C. § 112, second paragraph, for
allegedly failing to particularly point out and distinctly claim the subject matter which
Applicants regard as the invention. (Paper No. 12, at 6.) In particular, the Examiner
questioned the base claim references. Applicants thank the Examiner for pointing out these
minor errors. Applicants have followed the Examiner's suggestion and amended claims 202
and 203 to depend from claims 200 and 202, respectively. Thus, the Examiner's rejection
has been overcome.

Other Matters

Applicants have amended claims 152,161,169 and 2 1 0 to correct minor clerical and
typographical errors. These amendments introduce no new matter. Accordingly, their
consideration and entry are respectfully requested.

Applicants thank the Examiner for allowing claims 117, 120-175, 191-197, 199,201,

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Appl. No. 09/826,212

Applicants also thank the Examiner for consideration and entry of the amended
sequence listing filed March 26, 2003, to which reference is made in the Advisory Action
of April 9, 2003.

All of the stated grounds of objection and rejection have been properly traversed,
accommodated, or rendered moot. Applicants therefore respectfully request that the
Examiner reconsider all presently outstanding objections and rejections and that they be
withdrawn. Applicants believe that a full and complete reply has been made to the
outstanding Office Action and, as such, the present application is in condition for allowance
or Appeal. If the Examiner believes, for any reason, that personal communication will
expedite prosecution of this application, the Examiner is invited to telephone the
undersigned at the number provided.

Prompt and favorable consideration of this Amendment and Reply is respectfully
requested.

Date: May 12, 2003

1 100 New York Avenue, N.W.
Washington, D.C. 20005-3934
(202)^71^2600 -

::ODMA\MHODMA\SKGF_DC 1 ; 1 29 1 1 2;4

Conclusion

Respectfully submitted,

Sterne, Kessler, Goldstein & Fox p.l.l.c.

Gaby L. Longsworth
Agent for Applicants
Registration No. 47,756

SKGFRev. 4/9/02

• RECEIVED

MAY 1 5 2003

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Appl.No. 09/826,212

TECH CENTER 1600/2900

Version with markings to show changes made

In the Claims:

Pending claims 118, 119, 152, 161, 169, 176, 184, 194, 198, 200, 202, 203 and
210 were replaced by the following claims 118, 119, 152, 161, 169, 176, 184, 194, 198,
200, 202, 203 and 210:

118. (Once amended) The polypeptide of claim 117, wherein said polypeptide further
comprises [comprising] amino acids -25 to 233 of SEQ ID NO:2.

119. (Once amended) The polypeptide of claim 118, wherein said polypeptide further
comprises [comprising] amino acids -26 to 233 of SEQ ID NO:2.

1 52. (Once amended) The isolated polypeptide of claim 151, comprising the amino
acid sequence of the complete TNFR5 encoded by the cDNA clone contained in
ATCC Deposit No. 97788.

161. (Once amended) The polypeptide of claim 160, wherein the amino acid sequence
is at least 95% identical to the amino acid sequence of the mature TNFR5
encoded by the cDNA clone contained in ATCC Deposit No. 97788.

169. (Once amended) The polypeptide of claim 168, wherein the amino acid sequence
is at least 95% identical to the amino acid sequence of the complete TNFR5
encoded by the cDNA clone contained in ATCC Deposit No. 97788.

176. (Once amended) An isolated polypeptide comprising 30 contiguous amino acids
from amino acids 1 to 233 of SEQ ED NO:2; wherein said polypeptide binds
TRAIL [30 contiguous amino acids bind an antibody with specificity for a
reference polypeptide consisting of amino acids 1 to 233 of SEQ ID NO:2].

184. (Once amended) An isolated polypeptide comprising 50 contiguous amino acids
from -26 to 233 of SEQ ID NO:2; wherein said polypeptide binds TRAIL [50
contiguous amino acids bind an antibody with specificity for a reference
polypeptide consisting of amino acids 1 to 233 of SEQ ID NO:2].

194. (Once amended) The polypeptide of claim 192, wherein the first amino acid
sequence is (a).

198. (Once amended) The polypeptide of claim 196, wherein the first amino acid

sequence is (b).

200. (Once amended) The polypeptide of claim 191, wherein said second amino acid
sequence is (c).

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Appl. No. 09/826,212

202. (Once amended) The polypeptide of claim 200 [197], wherein said first amino
acid sequence is (c).

203. (Once amended) The polypeptide of claim 202 [198], which comprises amino
acids 27 to 123 of SEQ ID NO:2.

210. (Once amended) An isolated polypeptide selected from the group [the] consisting

(a) a polypeptide comprising 50 contiguous amino acids of the complete
TNFR5 encoded by the cDNA contained in ATCC Deposit No. 97788;

(b) a polypeptide comprising 30 contiguous amino acids of the mature
TNFR5 encoded by the cDNA contained in ATCC Deposit No. 97788;

(c) a polypeptide comprising 30 contiguous amino acids of the extracellular
domain of TNFR5 encoded by the cDNA contained in ATCC Deposit No.
97788; and

(d) a polypeptide comprising the transmembrane domain of TNFR5 encoded
by the cDNA contained in ATCC Deposit No. 97788;

wherein said polypeptide binds TRAIL [an antibody with specificity for a
reference polypeptide consisting of amino acids 1 to 233 of SEQ ID NO:2].

of: